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Device | VISX STAR EXCIMER LASER SYSTEM |
Generic Name | Excimer laser system |
Applicant | AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 |
PMA Number | P930016 |
Supplement Number | S012 |
Date Received | 07/14/2000 |
Decision Date | 04/27/2001 |
Product Code |
LZS |
Docket Number | 01M-0305 |
Notice Date | 07/23/2001 |
Advisory Committee |
Ophthalmic |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | Yes |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE VISX STAR S2 AND S3 EXCIMER LASER SYSTEMS. THE DEVICES ARE INDICATED FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS: 1) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF NO MORE THAN 0.5 D (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION; AND 2) IN PATIENTS 21 YEARS OF AGE OR OLDER IN TREATMENTS FOR THE REDUCTION OF ELIMINATION OF NATURALLY OCCURRING HYPEROPIA BETWEEN +05 AND +5.0 D SPHERE AT THE SPECTACLE PLANE WITH OR WITHOUT REFRACTIVE ASTIGMATISM UP TO +3.0 D, WITH A MAXIMUM MANIFEST REFRACTION SPHERICAL EQUIVALENT (MRSE) OF +6.0 D. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |